Thursday, November 17
12:00 PM
- 07:00 PM
EDT
Antigen Testing Available
12:00 PM
- 07:00 PM
EDT
Registration
05:00 PM
- 05:30 PM
EDT
VIP Reception
Everyone with a gold star on their badge is welcome!
Everyone with a gold star on their badge is welcome!
Everyone with a gold star on their badge is welcome!
05:30 PM
- 06:00 PM
EDT
New Participant & VIP Reception
Everyone with a gold or blue star on their badge is welcome!
Everyone with a gold or blue star on their badge is welcome!
Everyone with a gold or blue star on their badge is welcome!
06:00 PM
- 07:00 PM
EDT
Official Welcome Reception
All are welcome!
All are welcome!
All are welcome!
07:00 PM
- 08:30 PM
EDT
Hosted Reception: Syneos
All are welcome!
All are welcome!
All are welcome!
08:30 PM
- 10:00 PM
EDT
Premier Research Reception
All are welcome!
All are welcome!
All are welcome!
Friday, November 18
07:00 AM
- 07:45 AM
EDT
Breakfast
07:00 AM
- 05:00 PM
EDT
Antigen Testing Available
08:00 AM
- 12:00 PM
EDT
Keynote Sessions
- Amy Abernethy, President, Clinical Studies Platforms, Verily
- Vlad Coric, Chief Executive Officer, Biohaven
- Michelle Keefe, Chief Executive Officer, Syneos Health
- Najat Khan, Chief Data Science Officer & Global Head, Strategy & Operations, R&D, The Janssen Pharmaceutical Companies of Johnson & Johnson
- Candace Saldarini, Senior Director Applied Innovation, Otsuka
- Reed Tuckson, Managing Director, Tuckson Health Connections, LLC
- Brent Vaughan, CEO, Cognito Therapeutics
10:45 AM
- 10:55 AM
EDT
Innovation Showcase: Flatiron Health
- Hugh Levaux, Vice President, Clinical Research, Flatiron Health
10:55 AM
- 11:05 AM
EDT
Innovation Showcase: VersaTrial
- Mike Wenger, CEO and Founder, VersaTrial
11:05 AM
- 11:15 AM
EDT
Innovation Showcase: Cumulus Neuroscience
- Aman Bhatti, CEO, Cumulus Neuroscience
11:15 AM
- 11:25 AM
EDT
Innovation Showcase: ALCEDIAG
- Marianne Morini, Business Development Manager, ALCEDIAG
11:25 AM
- 11:35 AM
EDT
Innovation Showcase: Pluto Health
- Joy Bhosai MD MPH, CEO, Pluto Health
12:00 PM
EDT
Boxed Lunches
Please pick up your boxed lunch and proceed to your breakout room.
Please pick up your boxed lunch and proceed to your breakout room.
Please pick up your boxed lunch and proceed to your breakout room.
12:00 PM
- 01:50 PM
EDT
Spotlight Session: A 360º View of Diversity in Clinical Trials
Join Medidata and Circuit Clinical to learn more about the diversity of diversity in clinical research. We’ve got an all-star line-up of guests to speak to the value of data and benchmarking of diversity as well as site, patient, and sponsor perspectives. In this friendly and provoking session, Kelly and Dana will focus on improving access, awareness, and inclusion across the value chain. Adding to the talk show experience, top ten lists, thank you notes, and mean tweets will be shared. This is a can’t miss session of CNS!
Join Medidata and Circuit Clinical to learn more about the diversity of diversity in clinical research. We’ve got an all-star line-up of guests to speak to the value of data and benchmarking of diversity as well as site, patient, and sponsor perspectives. In this friendly and provoking session, Kelly and Dana will focus on improving access, awareness, and inclusion across the value chain. Adding to the talk show experience, top ten lists, thank you notes, and mean tweets will be shared. This is a can’t miss session of CNS!
Featured Speaker
Join Medidata and Circuit Clinical to learn more about the diversity of diversity in clinical research. We’ve got an all-star line-up of guests to speak to the value of data and benchmarking of diversity as well as site, patient, and sponsor perspectives. In this friendly and provoking session, Kelly and Dana will focus on improving access, awareness, and inclusion across the value chain. Adding to the talk show experience, top ten lists, thank you notes, and mean tweets will be shared. This is a can’t miss session of CNS!
- Aman Bhatti, CEO, Cumulus Neuroscience
- Christina Fawcett, Digital Engagement & Implementation Manager, GSK
- Kemi Olugemo, Head of Clinical Development, Laronde
- Josh Rose, VP, Head of Clinical Study Delivery and Site Solutions, CVS Health
- Del Smith, CEO, Acclinate
- Alicia Staley, VP, Patient Engagement, Medidata, a Dassault Systèmes company
- Dana Edwards, Chief Commercial Officer, Circuit Clinical
- Hassan Kadhim, Mr, Bristol Myers Squibb
- Kelly McKee, VP, Decentralized Clinical Trials, Medidata, a Dassault Systèmes company
- Daniel Perez, Global Head, Patient Experience, Diversity & Inclusion, Worldwide Clinical Trials
- Christine Von Raesfeld, CEO / Founder / patient advocate, People With Empathy
12:00 PM
- 02:30 PM
EDT
Neuroscience Spotlight
- Joshua Gordon, Director, National Institute of Mental Health
- Mike Egan, Vice President/Head of Neuroscience and Ophthalmology Departments, Merck & Co.
- Scott Braunstein, Chief Executive Officer, Marinus Pharmaceuticals
- Murali Doraiswamy, Dr, Duke University School of Medicine
- Terence Kelly, CEO, Perception Neuroscience
- Harry Tracy, President, NI Research
12:00 PM
- 12:15 PM
EDT
New Solutions: Empatica
- Marisa Cruz, Chief Medical Officer, Empatica
12:00 PM
- 12:50 PM
EDT
Spotlight Session: AI at the Point of Care - Faster Trials, Expanded Market Access
AI is a leapfrog technology in the field of healthcare that is already improving how we detect, monitor and treat diseases, from stroke to heart disease, at the point of care in thousands of hospitals. Now AI-powered care coordination is increasingly being used in the clinical trials to identify eligible and more diverse candidates, connect and research teams, and speed up enrollment. Post-launch, AI-powered care coordination is expanding market access by detecting disease in more patients and connecting the right patients to the right providers.
Join this session as a panel of experts discusses use cases and benefits as well as potential pitfalls of using AI at the point of care throughout clinical development and commercialization.
AI is a leapfrog technology in the field of healthcare that is already improving how we detect, monitor and treat diseases, from stroke to heart disease, at the point of care in thousands of hospitals. Now AI-powered care coordination is increasingly being used in the clinical trials to identify eligible and more diverse candidates, connect and research teams, and speed up enrollment. Post-launch, AI-powered care coordination is expanding market access by detecting disease in more patients and connecting the right patients to the right providers. Join this session as a panel of experts discusses use cases and benefits as well as potential pitfalls of using AI at the point of care throughout clinical development and commercialization.
Featured Speakers
Join this session as a panel of experts discusses use cases and benefits as well as potential pitfalls of using AI at the point of care throughout clinical development and commercialization.
AI is a leapfrog technology in the field of healthcare that is already improving how we detect, monitor and treat diseases, from stroke to heart disease, at the point of care in thousands of hospitals. Now AI-powered care coordination is increasingly being used in the clinical trials to identify eligible and more diverse candidates, connect and research teams, and speed up enrollment. Post-launch, AI-powered care coordination is expanding market access by detecting disease in more patients and connecting the right patients to the right providers. Join this session as a panel of experts discusses use cases and benefits as well as potential pitfalls of using AI at the point of care throughout clinical development and commercialization.
- Meri Scott, AVP, Digital Health Research and Development, Eli Lilly and Company
- Chris Mansi, Chief Executive Officer, Viz.ai
- Ryan Kennedy, Global Vice President, Product Strategy- HSGBU, Oracle
- Wendy Elliott, AVP Marcus Neuroscience, Marcus Neuroscience Institute, Baptist South
- Mason Tenaglia, Managing Partner, BioReinsurance Group
12:00 PM
- 12:50 PM
EDT
Spotlight Session: Innovation in At-Home Specimen Collection
Given the rise of trials at-home, what are the smart ways emerging to ensure reliable specimens can be collected, tracked and analyzed?
Given the rise of trials at-home, what are the smart ways emerging to ensure reliable specimens can be collected, tracked and analyzed?
Featured Speakers
Given the rise of trials at-home, what are the smart ways emerging to ensure reliable specimens can be collected, tracked and analyzed?
- Erwin Berthier, CTO, Tasso Inc
- Stacy Hurt, Patient Engagement Consultant, Independent
- Craig Lipset, Co-Chair, Decentralized Trials & Research Alliance
- Joy Somogyi, VP Marketing, ixlayer
- Shawn Tedman, VP of Biopharma Innovation, ixlayer
12:00 PM
- 12:50 PM
EDT
Spotlight Session: Connecting People, Data, and Technology to Make a Substantial, Lasting, and Measurable Impact on Patient and Site Burden
The pharma industry’s increasing focus on alleviating patient and site burden in clinical trials stems from the effect complexity, hence burden, has on study success. But it’s a hard goal to achieve – for a single study, let alone at scale across an entire portfolio of trials. Stakeholders from different facets of the clinical trial industry – patient, site, sponsor, and data/tech/service providers – will come together to discuss what patient and site burden means to them; how it is addressed in clinical trial planning and execution today; what meaningful improvement looks like and what is required to achieve this; and how we can connect people, data, and technology to make significant, sustainable improvements for all.
The pharma industry’s increasing focus on alleviating patient and site burden in clinical trials stems from the effect complexity, hence burden, has on study success. But it’s a hard goal to achieve – for a single study, let alone at scale across an entire portfolio of trials. Stakeholders from different facets of the clinical trial industry – patient, site, sponsor, and data/tech/service providers – will come together to discuss what patient and site burden means to them; how it is addressed in clinical trial planning and execution today; what meaningful improvement looks like and what is required to achieve this; and how we can connect people, data, and technology to make significant, sustainable improvements for all.
Featured Speaker
The pharma industry’s increasing focus on alleviating patient and site burden in clinical trials stems from the effect complexity, hence burden, has on study success. But it’s a hard goal to achieve – for a single study, let alone at scale across an entire portfolio of trials. Stakeholders from different facets of the clinical trial industry – patient, site, sponsor, and data/tech/service providers – will come together to discuss what patient and site burden means to them; how it is addressed in clinical trial planning and execution today; what meaningful improvement looks like and what is required to achieve this; and how we can connect people, data, and technology to make significant, sustainable improvements for all.
- Lauren Briggs, Head of Implementation - Patient Engagement & Recruitment, Citeline (formerly Informa Pharma Intelligence)
- Christina Fawcett, Digital Engagement & Implementation Manager, GSK
- Felicia Irvin, Executive Director of Business and Development, Centricity Research
- Joseph Kim, Chief Strategy Officer, ProofPilot
- Ted Trafford, Director of Business Development, Probity Medical Research
12:00 PM
- 12:50 PM
EDT
Spotlight Session: The Next Evolution of Study Delivery: Shifting the Paradigm to Bringing Trials Into the Community
The traditional dedicated clinical trial site approach has been the gold standard for a long time; however, there is a growing need to evolve how and where studies are conducted. Patients have become more mobile, more digitally enabled, and more discriminating about when to engage with clinical trials. At the same time, many are excluded from research. Delivery models for clinical trials have progressed, including a greater reliance on decentralized/hybrid trials (DCTs) and conducting studies in community settings, to improve the focus on patient access and to increase patient participation. The changing landscape allows for better patient optionality, giving them choices of where to participate: retail clinical site, home, virtual, or traditional site. This needed shift expands the clinical trial model to accelerate enrollment of diverse patient populations and embraces a faster and more effective study delivery. During this Signature Session, a panel of senior leaders will explore these innovations and how they lead to increased access, health equity, and engagement.
The traditional dedicated clinical trial site approach has been the gold standard for a long time; however, there is a growing need to evolve how and where studies are conducted. Patients have become more mobile, more digitally enabled, and more discriminating about when to engage with clinical trials. At the same time, many are excluded from research. Delivery models for clinical trials have progressed, including a greater reliance on decentralized/hybrid trials (DCTs) and conducting studies in community settings, to improve the focus on patient access and to increase patient participation. The changing landscape allows for better patient optionality, giving them choices of where to participate: retail clinical site, home, virtual, or traditional site. This needed shift expands the clinical trial model to accelerate enrollment of diverse patient populations and embraces a faster and more effective study delivery. During this Signature Session, a panel of senior leaders will explore these innovations and how they lead to increased access, health equity, and engagement.
Featured Speakers
The traditional dedicated clinical trial site approach has been the gold standard for a long time; however, there is a growing need to evolve how and where studies are conducted. Patients have become more mobile, more digitally enabled, and more discriminating about when to engage with clinical trials. At the same time, many are excluded from research. Delivery models for clinical trials have progressed, including a greater reliance on decentralized/hybrid trials (DCTs) and conducting studies in community settings, to improve the focus on patient access and to increase patient participation. The changing landscape allows for better patient optionality, giving them choices of where to participate: retail clinical site, home, virtual, or traditional site. This needed shift expands the clinical trial model to accelerate enrollment of diverse patient populations and embraces a faster and more effective study delivery. During this Signature Session, a panel of senior leaders will explore these innovations and how they lead to increased access, health equity, and engagement.
- Najat Khan, Chief Data Science Officer & Global Head, Strategy & Operations, R&D, The Janssen Pharmaceutical Companies of Johnson & Johnson
- Michelle Longmire, CEO, Medable
- Jamie Macdonald, CEO, Parexel
- Kyu Rhee, SVP, Aetna Chief Medical Officer, CVS Health
- Josh Rose, VP, Head of Clinical Study Delivery and Site Solutions, CVS Health
12:15 PM
- 12:30 PM
EDT
New Solutions: Evernorth
- Ria Westergaard, Director Product Innovation, Evernorth
12:30 PM
- 12:45 PM
EDT
New Solutions: Mural Health
- Samuel Whitaker, Co-CEO, Mural Health
12:45 PM
- 01:00 PM
EDT
New Solutions: Datacubed
- Kyle Hogan, President, Datacubed Health
- Natasha Massias, Solution Architect, Datacubed Health
01:00 PM
- 01:15 PM
EDT
New Solutions: Pro-ficiency
- David Hadden, President & Founder, Pro-ficiency
01:00 PM
- 01:50 PM
EDT
Spotlight Session: A Prescription for Clinical Trials: Setting Up DCT for Long-Term Success
Decentralized clinical trials (DCT) experienced a significant upsurge during the pandemic. The adoption of this important clinical trial system of capabilities is decelerating with the market partially returning to the ways of working before Pandemic-era restrictions necessitated widescale adoption of DCT techniques. There are several reasons for this slowdown, including the following:
- And vs Or: Many experts, including those at Cognizant, posited from the beginning that in the long term, DCT would represent one suite of arrows in the full quiver of clinical capabilities, versus supplanting the entire academic center based system of clinical trials
- Existing Infrastructure: Sponsors have made significant, multi-decades long investments in the traditional, pre-DCT systems, and this prior infrastructure represents an inertial mass that simply cannot be abandoned for the build phase of DCT
- In the fullness of time: The pandemic was too short to produce DCT stickiness. Many DCT-based improvements, including the emergence of DCT platforms, have not had sufficient time in market to overcome risk perceptions related to capacity and robustness of solutions `
Confident in the transformational impact of the DCT model, market-leading firms continue to invest in helping our industry reach an equilibrium where DCT constitutes 30-50% of overall studies. In this panel discussion, we will explore the following topics:
Critical capabilities required in the DCT model
- Lessons learned from the DCT experiments to date
- DCT platform providers who are emerging as market leaders
- What else must we do to bring about the promise of DCT?
Decentralized clinical trials (DCT) experienced a significant upsurge during the pandemic. The adoption of this important clinical trial system of capabilities is decelerating with the market partially returning to the ways of working before Pandemic-era restrictions necessitated widescale adoption of DCT techniques. There are several reasons for this slowdown, including the following: - And vs Or: Many experts, including those at Cognizant, posited from the beginning that in the long term, DCT would represent one suite of arrows in the full quiver of clinical capabilities, versus supplanting the entire academic center based system of clinical trials - Existing Infrastructure: Sponsors have made significant, multi-decades long investments in the traditional, pre-DCT systems, and this prior infrastructure represents an inertial mass that simply cannot be abandoned for the build phase of DCT - In the fullness of time: The pandemic was too short to produce DCT stickiness. Many DCT-based improvements, including the emergence of DCT platforms, have not had sufficient time in market to overcome risk perceptions related to capacity and robustness of solutions ` Confident in the transformational impact of the DCT model, market-leading firms continue to invest in helping our industry reach an equilibrium where DCT constitutes 30-50% of overall studies. In this panel discussion, we will explore the following topics: Critical capabilities required in the DCT model - Lessons learned from the DCT experiments to date - DCT platform providers who are emerging as market leaders - What else must we do to bring about the promise of DCT?
Featured Speakers
- And vs Or: Many experts, including those at Cognizant, posited from the beginning that in the long term, DCT would represent one suite of arrows in the full quiver of clinical capabilities, versus supplanting the entire academic center based system of clinical trials
- Existing Infrastructure: Sponsors have made significant, multi-decades long investments in the traditional, pre-DCT systems, and this prior infrastructure represents an inertial mass that simply cannot be abandoned for the build phase of DCT
- In the fullness of time: The pandemic was too short to produce DCT stickiness. Many DCT-based improvements, including the emergence of DCT platforms, have not had sufficient time in market to overcome risk perceptions related to capacity and robustness of solutions `
Confident in the transformational impact of the DCT model, market-leading firms continue to invest in helping our industry reach an equilibrium where DCT constitutes 30-50% of overall studies. In this panel discussion, we will explore the following topics:
Critical capabilities required in the DCT model
- Lessons learned from the DCT experiments to date
- DCT platform providers who are emerging as market leaders
- What else must we do to bring about the promise of DCT?
Decentralized clinical trials (DCT) experienced a significant upsurge during the pandemic. The adoption of this important clinical trial system of capabilities is decelerating with the market partially returning to the ways of working before Pandemic-era restrictions necessitated widescale adoption of DCT techniques. There are several reasons for this slowdown, including the following: - And vs Or: Many experts, including those at Cognizant, posited from the beginning that in the long term, DCT would represent one suite of arrows in the full quiver of clinical capabilities, versus supplanting the entire academic center based system of clinical trials - Existing Infrastructure: Sponsors have made significant, multi-decades long investments in the traditional, pre-DCT systems, and this prior infrastructure represents an inertial mass that simply cannot be abandoned for the build phase of DCT - In the fullness of time: The pandemic was too short to produce DCT stickiness. Many DCT-based improvements, including the emergence of DCT platforms, have not had sufficient time in market to overcome risk perceptions related to capacity and robustness of solutions ` Confident in the transformational impact of the DCT model, market-leading firms continue to invest in helping our industry reach an equilibrium where DCT constitutes 30-50% of overall studies. In this panel discussion, we will explore the following topics: Critical capabilities required in the DCT model - Lessons learned from the DCT experiments to date - DCT platform providers who are emerging as market leaders - What else must we do to bring about the promise of DCT?
- Bryan Hill, VP, Digital Health & Innovation, Cognizant
- Avi Kulkarni, SVP, Life Sciences SBU, Cognizant
- Craig Lipset, Co-Chair, Decentralized Trials & Research Alliance
- Sanskriti Thakur, Chief Growth Officer, Medable
01:00 PM
- 01:50 PM
EDT
Spotlight Session: Making Digital Measures Fit-For-Purpose in Alzheimer’s Trials
Digital tools offer novel insights into Alzheimer’s disease with the opportunity to measure, and by extension manage, what matters most to patients. However, to realise the benefits of digital measurement, understanding how to engage patients with these tools is key. Attendants to this session on Making digital measures fit-for-purpose in Alzheimer’s trials will learn:
-Development and validation frameworks for digital measures in clinical trials
-Feasibility and useability of digital measures with older adults
-Principles and process recommendations for digital measures in Alzheimer’s trials
Digital tools offer novel insights into Alzheimer’s disease with the opportunity to measure, and by extension manage, what matters most to patients. However, to realise the benefits of digital measurement, understanding how to engage patients with these tools is key. Attendants to this session on Making digital measures fit-for-purpose in Alzheimer’s trials will learn: -Development and validation frameworks for digital measures in clinical trials -Feasibility and useability of digital measures with older adults -Principles and process recommendations for digital measures in Alzheimer’s trials
Featured Speakers
-Development and validation frameworks for digital measures in clinical trials
-Feasibility and useability of digital measures with older adults
-Principles and process recommendations for digital measures in Alzheimer’s trials
Digital tools offer novel insights into Alzheimer’s disease with the opportunity to measure, and by extension manage, what matters most to patients. However, to realise the benefits of digital measurement, understanding how to engage patients with these tools is key. Attendants to this session on Making digital measures fit-for-purpose in Alzheimer’s trials will learn: -Development and validation frameworks for digital measures in clinical trials -Feasibility and useability of digital measures with older adults -Principles and process recommendations for digital measures in Alzheimer’s trials
- Francesca Cormack, Chief Scientist, Cambridge Cognition
- Aaron Koenig, Vice President, Medical Science Early, Sage Therapeutics
01:00 PM
- 01:50 PM
EDT
Spotlight Session: Leverage AI Driven NLP to Optimise Real World Data, Accelerate Clinical Trials and Deliver Precision Medicine
This session, led by Mark Messenbaugh (Advisor, Akrivia Health), sets out to discuss how real-world data can be leveraged for optimising clinical trials and precision neuroscience. Precision Neuroscience combines detailed clinical phenotyping, genomic sequencing, biobanking for ‘omics, and digital health to gain unique clinical and molecular insights into mental health and dementias. We will delve into how real-world data and evidence can support the development of drugs from target product profiles, clinical trial acceleration, and finally to provide the invaluable evidence needed for approval, to deliver these vital drugs to the caregivers and patients who need them most. *Join Akrivia Health, an Oxford-based company dedicated to the advancement of drug discovery and development for mental health and dementias, through real-world data, advanced AI driven NLP, and partnerships with mental health care providers to positively impact patient lives.
This session, led by Mark Messenbaugh (Advisor, Akrivia Health), sets out to discuss how real-world data can be leveraged for optimising clinical trials and precision neuroscience. Precision Neuroscience combines detailed clinical phenotyping, genomic sequencing, biobanking for ‘omics, and digital health to gain unique clinical and molecular insights into mental health and dementias. We will delve into how real-world data and evidence can support the development of drugs from target product profiles, clinical trial acceleration, and finally to provide the invaluable evidence needed for approval, to deliver these vital drugs to the caregivers and patients who need them most. *Join Akrivia Health, an Oxford-based company dedicated to the advancement of drug discovery and development for mental health and dementias, through real-world data, advanced AI driven NLP, and partnerships with mental health care providers to positively impact patient lives.
Featured Speaker
This session, led by Mark Messenbaugh (Advisor, Akrivia Health), sets out to discuss how real-world data can be leveraged for optimising clinical trials and precision neuroscience. Precision Neuroscience combines detailed clinical phenotyping, genomic sequencing, biobanking for ‘omics, and digital health to gain unique clinical and molecular insights into mental health and dementias. We will delve into how real-world data and evidence can support the development of drugs from target product profiles, clinical trial acceleration, and finally to provide the invaluable evidence needed for approval, to deliver these vital drugs to the caregivers and patients who need them most. *Join Akrivia Health, an Oxford-based company dedicated to the advancement of drug discovery and development for mental health and dementias, through real-world data, advanced AI driven NLP, and partnerships with mental health care providers to positively impact patient lives.
- Mark Messenbaugh, Consultant, Akrivia Health
- David Newton, Chief Operating Officer, Akrivia Health
- Gayle Wittenberg, VP, Neuroscience Data Science and Digital Health, Janssen Research & Development
- Sian Ratcliffe, Vice President, Head of Global Clinical Operations and Analytics & Data Sciences, Biogen
01:00 PM
- 01:50 PM
EDT
Spotlight Session: Powering Digital Biomarkers with Integrated Analytics Platforms
The evolution of digital health technologies and biomarkers in clinical trials will depend on ensuring the highest standards of data collection, transmission, security, quality, and analysis. Scalable clinical analytics platforms built within core engineering frameworks are the only way to ensure the integrity, repeatability, and value of data standards and insights. In this session, with groundbreaking NIH-funded neurology research and the WATCH-PD study as examples, we will lead an interactive discussion about how high-dimensional data sources--which allow patients to be monitored more precisely, objectively, and with higher frequency--and resulting development of digital biomarkers necessitate a new paradigm of engineering-forward analytics solutions.
The evolution of digital health technologies and biomarkers in clinical trials will depend on ensuring the highest standards of data collection, transmission, security, quality, and analysis. Scalable clinical analytics platforms built within core engineering frameworks are the only way to ensure the integrity, repeatability, and value of data standards and insights. In this session, with groundbreaking NIH-funded neurology research and the WATCH-PD study as examples, we will lead an interactive discussion about how high-dimensional data sources--which allow patients to be monitored more precisely, objectively, and with higher frequency--and resulting development of digital biomarkers necessitate a new paradigm of engineering-forward analytics solutions.
Featured Speakers
The evolution of digital health technologies and biomarkers in clinical trials will depend on ensuring the highest standards of data collection, transmission, security, quality, and analysis. Scalable clinical analytics platforms built within core engineering frameworks are the only way to ensure the integrity, repeatability, and value of data standards and insights. In this session, with groundbreaking NIH-funded neurology research and the WATCH-PD study as examples, we will lead an interactive discussion about how high-dimensional data sources--which allow patients to be monitored more precisely, objectively, and with higher frequency--and resulting development of digital biomarkers necessitate a new paradigm of engineering-forward analytics solutions.
- David Anderson, PhD, Principal Scientist, Clinical ink
- Matthew Rizzo, Chair, UNMC Department of Neurological Sciences; Chair, American Brain Coalition, University of Nebraska Medical Center
01:30 PM
- 01:45 PM
EDT
New Solutions: PCM Trials
- Ellen Weiss, Vice President, In-Home Solutions, Decentralized Clinical Trials, PCM Trials
02:00 PM
- 02:15 PM
EDT
New Solutions: ZS
- Emily Goldsher-Diamond, Manager, Human-Centered Trials, ZS Associates
- April Lewis, Head, Patient Centered Innovation, Clinical Development Excellence, ZS Associates
02:00 PM
- 02:50 PM
EDT
Spotlight Session: Psychedelics Forum
- Rolando Gutierrez-Esteinou, Chief Medical Officer, atai Life Sciences
- Amir Inamdar, Chief Medical Officer, Cybin Corp.
- Rishi Kakar, Chief Scientific Officer, Associate Meidical Director, Principal Investigator, Segal Trials
- Dan Karlin, Chief Medical Officer, MindMed
02:00 PM
- 02:50 PM
EDT
Spotlight Session: Digital Phenotyping in Rare Disease: Using Real-world Data to Accelerate the Cycle from Research to Care
- Zeenia Framroze, VP, Strategy & Operations, Smart Omix by Sharecare
- Franscesca Rinaldo, SVP Clinical Product & Innovation, Smart Omix by Sharecare
02:00 PM
- 02:50 PM
EDT
Spotlight Session: Digital Clinical Trials - Creating a Vision for the Future
The shift to decentralized trials has highlighted the need for better data management and direct digital connections that link sponsors, sites, and patients. Success with patient-centered digital clinical trials also hinges on engaging patients in various ways and managing huge volumes—and new forms—of data.
Join us as we explore the industry-wide move toward end-to-end digital trials for a seamless flow of information across patients, sites, and sponsors to create a connected trial ecosystem. We’ll discuss the key challenges of decentralized trials, how the industry can advance toward a digital and connected future, and the critical need for a strong data foundation.
The shift to decentralized trials has highlighted the need for better data management and direct digital connections that link sponsors, sites, and patients. Success with patient-centered digital clinical trials also hinges on engaging patients in various ways and managing huge volumes—and new forms—of data. Join us as we explore the industry-wide move toward end-to-end digital trials for a seamless flow of information across patients, sites, and sponsors to create a connected trial ecosystem. We’ll discuss the key challenges of decentralized trials, how the industry can advance toward a digital and connected future, and the critical need for a strong data foundation.
Featured Speakers
Join us as we explore the industry-wide move toward end-to-end digital trials for a seamless flow of information across patients, sites, and sponsors to create a connected trial ecosystem. We’ll discuss the key challenges of decentralized trials, how the industry can advance toward a digital and connected future, and the critical need for a strong data foundation.
The shift to decentralized trials has highlighted the need for better data management and direct digital connections that link sponsors, sites, and patients. Success with patient-centered digital clinical trials also hinges on engaging patients in various ways and managing huge volumes—and new forms—of data. Join us as we explore the industry-wide move toward end-to-end digital trials for a seamless flow of information across patients, sites, and sponsors to create a connected trial ecosystem. We’ll discuss the key challenges of decentralized trials, how the industry can advance toward a digital and connected future, and the critical need for a strong data foundation.
- Andrew Moniz, Vice President, Therapeutic Strategy & Innovation, Syneos Health
- Jim Reilly, VP, Development Cloud Strategy, Veeva Systems
- Lauren Sunshine, Global Procurement R&D, Clinical Technologies, Bristol Myers Squibb
- Richard Young, VP, Strategy, Vault CDMS, Veeva Systems
02:00 PM
- 02:50 PM
EDT
Spotlight Session: Partnering to Accelerate Clinical Development with AI
Clinical trials are becoming increasingly decentralized, customized, and built on precise predictions of clinical trial outcomes, which will lessen the resource burden on participants. Artificial Intelligence (AI) is at the forefront of this transformation by making clinical trials safer, more effective, and above all, patient-centric. Hear from a panel of industry leaders to discuss how pharma can partner with companies to implement innovative AI and how pharma is developing AI internally. The collective goal is to accelerate the clinical development process with AI, making trials significantly more efficient within an acceptable regulatory framework.
Clinical trials are becoming increasingly decentralized, customized, and built on precise predictions of clinical trial outcomes, which will lessen the resource burden on participants. Artificial Intelligence (AI) is at the forefront of this transformation by making clinical trials safer, more effective, and above all, patient-centric. Hear from a panel of industry leaders to discuss how pharma can partner with companies to implement innovative AI and how pharma is developing AI internally. The collective goal is to accelerate the clinical development process with AI, making trials significantly more efficient within an acceptable regulatory framework.
Featured Speaker
Clinical trials are becoming increasingly decentralized, customized, and built on precise predictions of clinical trial outcomes, which will lessen the resource burden on participants. Artificial Intelligence (AI) is at the forefront of this transformation by making clinical trials safer, more effective, and above all, patient-centric. Hear from a panel of industry leaders to discuss how pharma can partner with companies to implement innovative AI and how pharma is developing AI internally. The collective goal is to accelerate the clinical development process with AI, making trials significantly more efficient within an acceptable regulatory framework.
- Bryan J. Hansen, Director Data Science and Digital Health, Neuroscience, Janssen Research & Development
- Alex Morozov, Founder, Stealth
- Luis Olmos, Director Clinical Affairs, Unlearn.AI
- Venkat Sethuraman, SVP, Global Biometrics and Data Sciences, Bristol Myers Squibb
02:00 PM
- 02:50 PM
EDT
Spotlight Session: The Next Chapter for Digital Therapeutics
- Edward Cox, Digital Medicine Pioneer, Global Head and CEO, Pfizer
- Melinda Decker, Fractional Chief Commercial Officer & Digital Health Advisor, MAJ Global Consulting
- Marty Culjat, SVP, Global Head of Digital Medicine & Regulatory Innovation, EVERSANA
- Aaron Gani, Founder & CEO, BehaVR, Inc.
02:15 PM
- 02:30 PM
EDT
New Solutions: Clinical Research IO
02:30 PM
- 02:45 PM
EDT
New Solutions: OM1
- Carl Marci, Chief Psychiatrist & Managing Director, Mental Health & Neuroscience, OM1, Inc.
03:30 PM
- 05:00 PM
EDT
One to One Networking
05:00 PM
- 07:00 PM
EDT
Special Evening Event & Exhibits & Posters
View the ICNS abstract supplement here.
View the ICNS abstract supplement here.
View the ICNS abstract supplement here.
07:00 PM
- 08:00 PM
EDT
Chairman's Reception
Everyone with a red star on their badge is welcome!
Everyone with a red star on their badge is welcome!
Everyone with a red star on their badge is welcome!
08:00 PM
- 09:30 PM
EDT
Hosted Reception: Lightship
All are welcome!
All are welcome!
All are welcome!
09:00 PM
EDT
Betty Woodaman Fundraiser
All are welcome!
All are welcome!
All are welcome!
09:00 PM
EDT
Pink Socks Meet Up
All are welcome!
All are welcome!
All are welcome!
Saturday, November 19
07:00 AM
- 07:45 PM
EDT
Breakfast
07:00 AM
- 05:00 PM
EDT
Antigen Testing Available
Please note that you must provide proof of a negative COVID test to the registration desk before receiving your badge.
Please note that you must provide proof of a negative COVID test to the registration desk before receiving your badge.
Please note that you must provide proof of a negative COVID test to the registration desk before receiving your badge.
08:00 AM
- 12:00 PM
EDT
Keynote Session
- Ramita Tandon, Chief Clinical Trials Officer, Walgreens Boots Alliance
- Amy Abernethy, President, Clinical Studies Platforms, Verily
- Derk Arts, Founder and CEO, Castor
- Florian Brand, Co-Founder, CEO, atai Life Sciences
- David Coman, Chief Executive Officer, Science 37
- Anthony Costello, CEO, Patient Cloud, Medidata, a Dassault Systèmes company
- Irfan Khan, CEO, Circuit Clinical
- Robert Litman, M.D., Chief Scientific Officer, Psychiatry, CenExel CBH Health
- Antony Loebel, Sunovion Pharmaceuticals
- Michelle Longmire, CEO, Medable
- Jamie Macdonald, CEO, Parexel
- David MacMurchy, Chief Executive Officer, Lightship
- Ekaterina Malievskaia, Chief Innovation Officer, COMPASS Pathways
- Kabir Nath, CEO, COMPASS Pathways
- Steve Paul, CEO & President, Karuna Therapeutics
- Srinivas Rao, Co-founder & Chief Scientific Officer, atai Life Sciences
- John Reites, CEO, THREAD
- Colin Sauder, Sr. Director Clinical Scientist, Karuna Therapeutics
- Bonnie Segal, President, Segal Trials
- Venkat Sethuraman, SVP, Global Biometrics and Data Sciences, Bristol Myers Squibb
- James Williams, Head, Biogen Digital Health External Innovation, Biogen
- Alexandria Wise, Global Head, Therapeutic Strategy & Innovation, Syneos Health
11:10 AM
- 11:20 AM
EDT
Innovation Showcase: Verily
- Amy Abernethy, President, Clinical Studies Platforms, Verily
11:20 AM
- 11:30 AM
EDT
Innovation Showcase: Pro-ficiency
- David Hadden, President & Founder, Pro-ficiency
11:30 AM
- 11:40 AM
EDT
Innovation Showcase: Proof Pilot
- Joseph Kim, Chief Strategy Officer, ProofPilot
11:40 AM
- 11:50 AM
EDT
Innovation Showcase: Deliberate AI
- Marc Aafjes, CEO, Deliberate AI
12:00 PM
EDT
Boxed Lunches
You will pick up your boxed lunch and proceed to your breakout room.
You will pick up your boxed lunch and proceed to your breakout room.
You will pick up your boxed lunch and proceed to your breakout room.
12:00 PM
- 02:00 PM
EDT
Neuroscience Spotlight
- Chad Beyer, CEO, Kures Inc
- Mark Corrigan, Board Member, Founder, Pres. R&D, Tremeau Pharmaceuticals
- Peter DiStefano, CSO, Cognesy Therapeutics
- Mikael Eliasson, COO, Alto Neuroscience
- Magali Haas, CEO & President, Cohen Veterans Bioscience
- Scott Kollins, Chief Medical Officer, Holmusk
- Gayle Wittenberg, VP, Neuroscience Data Science and Digital Health, Janssen Research & Development
- Gregory Ryslik, Executive Vice President, AI, Engineering, Technology & Digital Health Research COMPASS Pathways, COMPASS Pathways
12:00 PM
- 12:10 PM
EDT
Afternoon Innovation Showcase: Neuroelectrics
- Ana Maiques, CEO and Co-Founder, Neuroelectrics
12:00 PM
- 12:50 PM
EDT
Spotlight Session: What Is Real Patient Engagement?
The life sciences industry has been talking about patient centricity and patient engagement for a long time. We have the technology and resources to create a path to meet patients where they are, but for the most part, the real point is still being missed. Join us for a lively discussion that includes current views of patient engagement – opportunities to address the challenges of existing strategies within the conduct of a clinical study; how do we currently measure patient engagement, and how do we improve it; how patient centricity will evolve as digital tools continue to augment or replace face-to-face interactions across all patient populations; how technology can foster a more patient-empathic approach to study participation and unlock value for all stakeholders – patients, caregivers, sites and sponsors.
The life sciences industry has been talking about patient centricity and patient engagement for a long time. We have the technology and resources to create a path to meet patients where they are, but for the most part, the real point is still being missed. Join us for a lively discussion that includes current views of patient engagement – opportunities to address the challenges of existing strategies within the conduct of a clinical study; how do we currently measure patient engagement, and how do we improve it; how patient centricity will evolve as digital tools continue to augment or replace face-to-face interactions across all patient populations; how technology can foster a more patient-empathic approach to study participation and unlock value for all stakeholders – patients, caregivers, sites and sponsors.
Featured Speaker
The life sciences industry has been talking about patient centricity and patient engagement for a long time. We have the technology and resources to create a path to meet patients where they are, but for the most part, the real point is still being missed. Join us for a lively discussion that includes current views of patient engagement – opportunities to address the challenges of existing strategies within the conduct of a clinical study; how do we currently measure patient engagement, and how do we improve it; how patient centricity will evolve as digital tools continue to augment or replace face-to-face interactions across all patient populations; how technology can foster a more patient-empathic approach to study participation and unlock value for all stakeholders – patients, caregivers, sites and sponsors.
- Clare Grace, Chief Patient Officer, Parexel
- Georgia Mitsi, Gerenal Manager, VR and Mental Health, Biogen Digital Health
- Steve Rosenberg, CEO, uMotif
- Andrea Valente, CEO, ClinOne
- Katherine Vandebelt, Global VP Clinical Innovation, Oracle
12:00 PM
- 12:50 PM
EDT
Spotlight Session: Advancing Digital Biomarkers in Parkinson’s Disease Clinical Trials
Digital biomarkers have the potential to aid in diagnosing and/or treating Parkinson’s and allow patients to begin treatment while still in the disease’s early stages. This panel will discuss advancements with digital biomarkers, such as clinical-grade speech analytics to data from Verily watch, to detect progression in early Parkinson’s or the pre-diagnostic stage. Digitally collected data points could potentially be used to predict an individual’s progression with the disease. Hear perspectives on the future of digital biomarkers in Parkinson’s clinical trials.
Digital biomarkers have the potential to aid in diagnosing and/or treating Parkinson’s and allow patients to begin treatment while still in the disease’s early stages. This panel will discuss advancements with digital biomarkers, such as clinical-grade speech analytics to data from Verily watch, to detect progression in early Parkinson’s or the pre-diagnostic stage. Digitally collected data points could potentially be used to predict an individual’s progression with the disease. Hear perspectives on the future of digital biomarkers in Parkinson’s clinical trials.
Featured Speaker
Digital biomarkers have the potential to aid in diagnosing and/or treating Parkinson’s and allow patients to begin treatment while still in the disease’s early stages. This panel will discuss advancements with digital biomarkers, such as clinical-grade speech analytics to data from Verily watch, to detect progression in early Parkinson’s or the pre-diagnostic stage. Digitally collected data points could potentially be used to predict an individual’s progression with the disease. Hear perspectives on the future of digital biomarkers in Parkinson’s clinical trials.
- Chris Benko, CEO, Koneksa
- Samantha Hutten, PhD, Director, Discovery and Translational Research, The Michael J. Fox Foundation for Parkinson's Research
- Judy Smythe, CEO, Aural Analytics
- John Wagner, MD, PhD., Chief Medical Officer, Koneksa
12:00 PM
- 01:50 PM
EDT
Spotlight Session: DCT Town Hall
- Derk Arts, Founder and CEO, Castor
- David Coman, Chief Executive Officer, Science 37
- Scott Dixon, Chief Commercial Officer, ObvioHealth
- Ivan Jarry, CEO, ObvioHealth
- Michelle Longmire, CEO, Medable
- David MacMurchy, Chief Executive Officer, Lightship
- Kelly McKee, VP, Decentralized Clinical Trials, Medidata, a Dassault Systèmes company
- Ritesh Patel, Senior Partner - Global Digital Health, FINN Partners
- John Reites, CEO, THREAD
- MaryAnne Rizk, Chief Strategy Officer, Medable
- Todd Rudo, M.D., Chief Medical Officer, Clario
- Ramita Tandon, Chief Clinical Trials Officer, Walgreens Boots Alliance
12:10 PM
- 12:20 PM
EDT
Afternoon Innovation Showcase: Medable
- Ingrid Oakley-Girvan, SVP of Research, Value and Strategy, Medable
12:20 PM
- 12:30 PM
EDT
Afternoon Innovation Showcase: Beacon Biosignals
- Jacob Donoghue, CEO, Beacon Biosignals
12:30 PM
- 12:40 PM
EDT
Afternoon Innovation Showcase: InSilicoTrials
- Mario Torchia, Executive Vice President Sales & Marketing, InSilicoTrials
12:40 PM
- 12:50 PM
EDT
Afternoon Innovation Showcase: Vivid Genomics
- Julie Collens, CEO, Vivid Genomics
01:00 PM
- 01:10 PM
EDT
Afternoon Innovation Showcase: Clinical Ink
- David Anderson, PhD, Principal Scientist, Clinical ink
01:00 PM
- 01:50 PM
EDT
Spotlight Session: Digital Phenotypes of Brain Diseases- Transforming Alzheimer's Disease Drug Development and Disease Management
- Sean Gregory, VP, Health Economics & Market Access, Cognito Therapeutics
- Travis Bond, CEO, Altoida
- Bryan J. Hansen, Director Data Science and Digital Health, Neuroscience, Janssen Research & Development
- Ana Maiques, CEO and Co-Founder, Neuroelectrics
- Georgia Mitsi, Gerenal Manager, VR and Mental Health, Biogen Digital Health
01:00 PM
- 01:50 PM
EDT
Spotlight Session: RWE for Behavioral Health: Challenges and Opportunities
Fueled in part by the 21 st Century Cures Act, there has been an increased emphasis from FDAand other stakeholders on the use of Real-World Data (RWD) and Real-World Evidence (RWE) in the treatment development process. There has been considerable progress incorporating RWE into the clinical evidence generation plans across a range of therapeutic areas (eg., oncology).
Indeed, the COVID-19 pandemic has provided an important impetus to refine the way industry and regulatory stakeholders think about RWE. In spite of these advances, there has been relatively less progress in the use of RWE in
behavioral and mental health. There are few, if any, use cases of regulatory decisions in across psychiatric indications that have been influenced or informed by RWE.
There are a number of potential reasons for this, including the nature and quality of real-world data that are routinely gathered in behavioral health clinical settings. Patients seen in clinical trials are also not representative of those seen in routine care, making comparability across settings difficult to
evaluate. Finally, data gathered in routine clinical care, is either subjective and argely unstructured (as is the case with data from electronic health records) or lacks depth and clinical richness (as is the case with insurance claims data).
This Spotlight Session will focus on ways that RWE can be used more effectively in behavioral health research. The continued development and refinement of data science methods such as natural language processing provide tools to help derive structure and clinical meaning from the traditionally variable and unstructured data captured in routine behavioral health care. In addition, the explosion of tools to gather, aggregate, and process vast amounts of patient generated health data holds great promise to augment the kinds of information gathered in clinical settings, which often do not capture the most important features of a patient’s journey.
The overall objective of this panel is to take a critical and in-depth look at the challenges for using RWE in behavioral health and to explore opportunities for innovation. We aim to solicit input from diverse stakeholders to serve as an important point of departure for a journey to help define the field of RWE for behavioral health.
Fueled in part by the 21 st Century Cures Act, there has been an increased emphasis from FDAand other stakeholders on the use of Real-World Data (RWD) and Real-World Evidence (RWE) in the treatment development process. There has been considerable progress incorporating RWE into the clinical evidence generation plans across a range of therapeutic areas (eg., oncology). Indeed, the COVID-19 pandemic has provided an important impetus to refine the way industry and regulatory stakeholders think about RWE. In spite of these advances, there has been relatively less progress in the use of RWE in behavioral and mental health. There are few, if any, use cases of regulatory decisions in across psychiatric indications that have been influenced or informed by RWE. There are a number of potential reasons for this, including the nature and quality of real-world data that are routinely gathered in behavioral health clinical settings. Patients seen in clinical trials are also not representative of those seen in routine care, making comparability across settings difficult to evaluate. Finally, data gathered in routine clinical care, is either subjective and argely unstructured (as is the case with data from electronic health records) or lacks depth and clinical richness (as is the case with insurance claims data). This Spotlight Session will focus on ways that RWE can be used more effectively in behavioral health research. The continued development and refinement of data science methods such as natural language processing provide tools to help derive structure and clinical meaning from the traditionally variable and unstructured data captured in routine behavioral health care. In addition, the explosion of tools to gather, aggregate, and process vast amounts of patient generated health data holds great promise to augment the kinds of information gathered in clinical settings, which often do not capture the most important features of a patient’s journey. The overall objective of this panel is to take a critical and in-depth look at the challenges for using RWE in behavioral health and to explore opportunities for innovation. We aim to solicit input from diverse stakeholders to serve as an important point of departure for a journey to help define the field of RWE for behavioral health.
Featured Speaker
Indeed, the COVID-19 pandemic has provided an important impetus to refine the way industry and regulatory stakeholders think about RWE. In spite of these advances, there has been relatively less progress in the use of RWE in
behavioral and mental health. There are few, if any, use cases of regulatory decisions in across psychiatric indications that have been influenced or informed by RWE.
There are a number of potential reasons for this, including the nature and quality of real-world data that are routinely gathered in behavioral health clinical settings. Patients seen in clinical trials are also not representative of those seen in routine care, making comparability across settings difficult to
evaluate. Finally, data gathered in routine clinical care, is either subjective and argely unstructured (as is the case with data from electronic health records) or lacks depth and clinical richness (as is the case with insurance claims data).
This Spotlight Session will focus on ways that RWE can be used more effectively in behavioral health research. The continued development and refinement of data science methods such as natural language processing provide tools to help derive structure and clinical meaning from the traditionally variable and unstructured data captured in routine behavioral health care. In addition, the explosion of tools to gather, aggregate, and process vast amounts of patient generated health data holds great promise to augment the kinds of information gathered in clinical settings, which often do not capture the most important features of a patient’s journey.
The overall objective of this panel is to take a critical and in-depth look at the challenges for using RWE in behavioral health and to explore opportunities for innovation. We aim to solicit input from diverse stakeholders to serve as an important point of departure for a journey to help define the field of RWE for behavioral health.
Fueled in part by the 21 st Century Cures Act, there has been an increased emphasis from FDAand other stakeholders on the use of Real-World Data (RWD) and Real-World Evidence (RWE) in the treatment development process. There has been considerable progress incorporating RWE into the clinical evidence generation plans across a range of therapeutic areas (eg., oncology). Indeed, the COVID-19 pandemic has provided an important impetus to refine the way industry and regulatory stakeholders think about RWE. In spite of these advances, there has been relatively less progress in the use of RWE in behavioral and mental health. There are few, if any, use cases of regulatory decisions in across psychiatric indications that have been influenced or informed by RWE. There are a number of potential reasons for this, including the nature and quality of real-world data that are routinely gathered in behavioral health clinical settings. Patients seen in clinical trials are also not representative of those seen in routine care, making comparability across settings difficult to evaluate. Finally, data gathered in routine clinical care, is either subjective and argely unstructured (as is the case with data from electronic health records) or lacks depth and clinical richness (as is the case with insurance claims data). This Spotlight Session will focus on ways that RWE can be used more effectively in behavioral health research. The continued development and refinement of data science methods such as natural language processing provide tools to help derive structure and clinical meaning from the traditionally variable and unstructured data captured in routine behavioral health care. In addition, the explosion of tools to gather, aggregate, and process vast amounts of patient generated health data holds great promise to augment the kinds of information gathered in clinical settings, which often do not capture the most important features of a patient’s journey. The overall objective of this panel is to take a critical and in-depth look at the challenges for using RWE in behavioral health and to explore opportunities for innovation. We aim to solicit input from diverse stakeholders to serve as an important point of departure for a journey to help define the field of RWE for behavioral health.
- Joy Bhosai MD MPH, CEO, Pluto Health
- Scott Kollins, Chief Medical Officer, Holmusk
- Vikas Mohan Sharma, Head of Medicine, CNS, Retinal Health and Emerging Areas, Boehringer Ingelheim
- Christine Von Raesfeld, CEO / Founder / patient advocate, People With Empathy
- Kaan Tunceli, Interim Head, Global Value and Real World Evidence, Otsuka
- Matthew Veatch, Managing Director, Revesight Consulting
01:00 PM
- 01:50 PM
EDT
Spotlight Session: From Bench to Bedside, How Effective Collaboration Aims at Delivering Digital Impact from Research to Commercial
Through a collaborative partnership, Huma and Janssen are committed to delivering innovative solutions to address today’s greatest challenges. Through a partnership leveraging more than a decade long experience in delivering digital solutions for care and research, coupled with world renown clinical and research expertise delivering safe and effective therapies for some of the most complex diseases, this collaboration aims at developing, validating and ultimately launching digital solutions to augment how diseases are measured ultimately delivering a digital companion solution through a truly patient-centric experience.
In this session, we will focus on sharing insights from co-developing and validating a novel way to measure the progression of Alzheimer's through our ReVeRe project, as well as sharing our common vision to leveraging digital to effectively provide a companion solution to better address the delivery of therapeutics in the real world.
A true example of what could happen when collaboration for novel solutions takes place.
Through a collaborative partnership, Huma and Janssen are committed to delivering innovative solutions to address today’s greatest challenges. Through a partnership leveraging more than a decade long experience in delivering digital solutions for care and research, coupled with world renown clinical and research expertise delivering safe and effective therapies for some of the most complex diseases, this collaboration aims at developing, validating and ultimately launching digital solutions to augment how diseases are measured ultimately delivering a digital companion solution through a truly patient-centric experience. In this session, we will focus on sharing insights from co-developing and validating a novel way to measure the progression of Alzheimer's through our ReVeRe project, as well as sharing our common vision to leveraging digital to effectively provide a companion solution to better address the delivery of therapeutics in the real world. A true example of what could happen when collaboration for novel solutions takes place.
Featured Speakers
In this session, we will focus on sharing insights from co-developing and validating a novel way to measure the progression of Alzheimer's through our ReVeRe project, as well as sharing our common vision to leveraging digital to effectively provide a companion solution to better address the delivery of therapeutics in the real world.
A true example of what could happen when collaboration for novel solutions takes place.
Through a collaborative partnership, Huma and Janssen are committed to delivering innovative solutions to address today’s greatest challenges. Through a partnership leveraging more than a decade long experience in delivering digital solutions for care and research, coupled with world renown clinical and research expertise delivering safe and effective therapies for some of the most complex diseases, this collaboration aims at developing, validating and ultimately launching digital solutions to augment how diseases are measured ultimately delivering a digital companion solution through a truly patient-centric experience. In this session, we will focus on sharing insights from co-developing and validating a novel way to measure the progression of Alzheimer's through our ReVeRe project, as well as sharing our common vision to leveraging digital to effectively provide a companion solution to better address the delivery of therapeutics in the real world. A true example of what could happen when collaboration for novel solutions takes place.
- Nico O'Kuinghttons, VP Commercial - DCT, Huma
- Gayle Wittenberg, VP, Neuroscience Data Science and Digital Health, Janssen Research & Development
- Dan Vahdat, CEO, Huma
01:10 PM
- 01:20 PM
EDT
Afternoon Innovation Showcase: Curavit Clinical Research
- Joel Morse, CEO & Co-founder, Curavit Clinical Research
01:20 PM
- 01:30 PM
EDT
Afternoon Innovation Showcase : Smart Omix by Sharecare
- Zeenia Framroze, VP, Strategy & Operations, Smart Omix by Sharecare
01:30 PM
- 01:40 PM
EDT
Afternoon Innovation Showcase: Faro Health
- Scott Chetham, CEO, Faro Health Inc.
02:00 PM
- 02:10 PM
EDT
Afternoon Innovation Showcase: Delve Health
- Wessam Sonbol, CEO, Delve Health
02:00 PM
- 02:50 PM
EDT
Spotlight Session: Addressing Multiple Study Challenges Through Clinical Trial Intelligence
This session highlights how our partners advance their analytics maturity by leveraging their operational and clinical data, along with a deep compendium of proprietary 1st-party Clinical Research Data (CRD). Starting with descriptive analytics, we outline key requirements and characteristics required to shape an analytics foundation and examine fundamental use cases, such as study operational health and eTMF insights. We then explore predictive analytics use cases using multivariate clustering and Bayesian probability models, which enables our partners to anticipate and adjust to future events, ensuring optimal oversight on even the most complex studies.
This session highlights how our partners advance their analytics maturity by leveraging their operational and clinical data, along with a deep compendium of proprietary 1st-party Clinical Research Data (CRD). Starting with descriptive analytics, we outline key requirements and characteristics required to shape an analytics foundation and examine fundamental use cases, such as study operational health and eTMF insights. We then explore predictive analytics use cases using multivariate clustering and Bayesian probability models, which enables our partners to anticipate and adjust to future events, ensuring optimal oversight on even the most complex studies.
Speaker
This session highlights how our partners advance their analytics maturity by leveraging their operational and clinical data, along with a deep compendium of proprietary 1st-party Clinical Research Data (CRD). Starting with descriptive analytics, we outline key requirements and characteristics required to shape an analytics foundation and examine fundamental use cases, such as study operational health and eTMF insights. We then explore predictive analytics use cases using multivariate clustering and Bayesian probability models, which enables our partners to anticipate and adjust to future events, ensuring optimal oversight on even the most complex studies.
- Todd Johnson, Vice President, Customer Success, Lokavant
- Rohit Nambisan, CEO, Lokavant
- Shuji Ozawa, Division Head of Clinical Operation Promotion Division, CMIC
02:00 PM
- 02:50 PM
EDT
Spotlight Session: Improving Clinical Trial Outcomes by Improving the Participants' Experience
Participant drop out rates have a material negative impact on the economics of clinical research. Failure to retain participants puts study timelines at risk, jeopardizes study budgets, compromises data quality, and delays the approval of therapies that can positively impact the broader global community. Participants are critical to the success of the study. They are the source of the data. And without their disciplined participation the industry would not be able to bring new therapies to market. Historically, we have been hesitant to adopt modern tech, or invest in services that are designed to improve the participants' experience. Why are we so hesitant to invest in order to eliminate obstacles, improve accessibility, diversify participant populations, reduce financial barriers, and produce positively raving participants? What would happen if we made it easy to be a participant? What if the experience of being in the trial resulted in referrals from the participants themselves? During our spotlight session we will explore the various ways that the current state of trials makes it difficult, an in cases nearly impossible, for both healthy and sick populations to participate in research. And we will link the benefits of improving the participants' experience to the business case for investing in solutions. That is, what is the return to the study sponsor, and other stakeholders, from investing in solutions to make it easier to be a participant.
Participant drop out rates have a material negative impact on the economics of clinical research. Failure to retain participants puts study timelines at risk, jeopardizes study budgets, compromises data quality, and delays the approval of therapies that can positively impact the broader global community. Participants are critical to the success of the study. They are the source of the data. And without their disciplined participation the industry would not be able to bring new therapies to market. Historically, we have been hesitant to adopt modern tech, or invest in services that are designed to improve the participants' experience. Why are we so hesitant to invest in order to eliminate obstacles, improve accessibility, diversify participant populations, reduce financial barriers, and produce positively raving participants? What would happen if we made it easy to be a participant? What if the experience of being in the trial resulted in referrals from the participants themselves? During our spotlight session we will explore the various ways that the current state of trials makes it difficult, an in cases nearly impossible, for both healthy and sick populations to participate in research. And we will link the benefits of improving the participants' experience to the business case for investing in solutions. That is, what is the return to the study sponsor, and other stakeholders, from investing in solutions to make it easier to be a participant.
Featured Speaker
Participant drop out rates have a material negative impact on the economics of clinical research. Failure to retain participants puts study timelines at risk, jeopardizes study budgets, compromises data quality, and delays the approval of therapies that can positively impact the broader global community. Participants are critical to the success of the study. They are the source of the data. And without their disciplined participation the industry would not be able to bring new therapies to market. Historically, we have been hesitant to adopt modern tech, or invest in services that are designed to improve the participants' experience. Why are we so hesitant to invest in order to eliminate obstacles, improve accessibility, diversify participant populations, reduce financial barriers, and produce positively raving participants? What would happen if we made it easy to be a participant? What if the experience of being in the trial resulted in referrals from the participants themselves? During our spotlight session we will explore the various ways that the current state of trials makes it difficult, an in cases nearly impossible, for both healthy and sick populations to participate in research. And we will link the benefits of improving the participants' experience to the business case for investing in solutions. That is, what is the return to the study sponsor, and other stakeholders, from investing in solutions to make it easier to be a participant.
- Tabatha Cirgenski - Ruiz, Director of Marketing, Segal Trials
- Keri McDonough, Head, Patient Voice Consortium, Vice President, Medical and Scientific Strategy, Syneos Health
- Del Smith, CEO, Acclinate
- Samuel Whitaker, Co-CEO, Mural Health
- Gaelan Ritter, head of analytics innovation and digital health, Bristol Myers Squibb
02:00 PM
- 02:50 PM
EDT
Spotlight Session: Behavioral Science Informing Patient and Caregiver Experience
The focus on patient experience in clinical research is rapidly advancing, aided by tidal waves of data, the application of behavioral sciences, and the interpretation of regulatory guidance that urges sponsors to seek patient input and preferences throughout drug development. These converging forces are driving novel approaches for clinical trial design and patient support programs. Behavioral science techniques can inform the patient journey earlier in diagnosis and at different stages of decision-making about clinical trials as care or as an alternative treatment option. This spotlight session panel convenes a variety of expert perspectives on quantitative data driven methodologies but also qualitative research approaches transforming the clinical trial experience for patients and caregivers.
The focus on patient experience in clinical research is rapidly advancing, aided by tidal waves of data, the application of behavioral sciences, and the interpretation of regulatory guidance that urges sponsors to seek patient input and preferences throughout drug development. These converging forces are driving novel approaches for clinical trial design and patient support programs. Behavioral science techniques can inform the patient journey earlier in diagnosis and at different stages of decision-making about clinical trials as care or as an alternative treatment option. This spotlight session panel convenes a variety of expert perspectives on quantitative data driven methodologies but also qualitative research approaches transforming the clinical trial experience for patients and caregivers.
Featured Speaker
The focus on patient experience in clinical research is rapidly advancing, aided by tidal waves of data, the application of behavioral sciences, and the interpretation of regulatory guidance that urges sponsors to seek patient input and preferences throughout drug development. These converging forces are driving novel approaches for clinical trial design and patient support programs. Behavioral science techniques can inform the patient journey earlier in diagnosis and at different stages of decision-making about clinical trials as care or as an alternative treatment option. This spotlight session panel convenes a variety of expert perspectives on quantitative data driven methodologies but also qualitative research approaches transforming the clinical trial experience for patients and caregivers.
- Clare Grace, Chief Patient Officer, Parexel
- Tina Aswani Omprakash, Co-Founder and Health & Disability Patient, Expert & Advocate, South Asian IBD Alliance
- Alex Klein, Founder & Lead Designer, Team Human Innovation
- Ash Rishi, CEO, Couch
02:00 PM
- 02:50 PM
EDT
Spotlight Session: Real-Life Functional Outcomes Using Digital Health Technologies as Regulatory Endorsed Clinical Endpoints
Building on the momentum in decentralized clinical trials driven by the pandemic, regulatory agencies have taken action in 2022 to facilitate the adoption of Digital Health Technologies (DHTs) in clinical trials. In January, FDA published its first draft guidance on the use of DHTs in clinical investigation. The use of DHT is also part of the scientific strategy of FDA’s five-year Action Plan for the ALS act released in June. With these significant regulatory milestones, the time is ripe to adopt DHT data as a core strategy to advance clinical development. This session will discuss the opportunities and challenges with using wearable DHT data to support clinical efficacy, the past and future of wearable technologies, and the path forward to meaningful clinical endpoints from both vendor and sponsor perspectives.
Building on the momentum in decentralized clinical trials driven by the pandemic, regulatory agencies have taken action in 2022 to facilitate the adoption of Digital Health Technologies (DHTs) in clinical trials. In January, FDA published its first draft guidance on the use of DHTs in clinical investigation. The use of DHT is also part of the scientific strategy of FDA’s five-year Action Plan for the ALS act released in June. With these significant regulatory milestones, the time is ripe to adopt DHT data as a core strategy to advance clinical development. This session will discuss the opportunities and challenges with using wearable DHT data to support clinical efficacy, the past and future of wearable technologies, and the path forward to meaningful clinical endpoints from both vendor and sponsor perspectives.
Featured Speaker
Building on the momentum in decentralized clinical trials driven by the pandemic, regulatory agencies have taken action in 2022 to facilitate the adoption of Digital Health Technologies (DHTs) in clinical trials. In January, FDA published its first draft guidance on the use of DHTs in clinical investigation. The use of DHT is also part of the scientific strategy of FDA’s five-year Action Plan for the ALS act released in June. With these significant regulatory milestones, the time is ripe to adopt DHT data as a core strategy to advance clinical development. This session will discuss the opportunities and challenges with using wearable DHT data to support clinical efficacy, the past and future of wearable technologies, and the path forward to meaningful clinical endpoints from both vendor and sponsor perspectives.
- Christine Guo, Chief Scientific Officer, Actigraph
- Michael Philcock, Digital Solutions Consultant, Actigraph
- Everett Crosland, Chief Commercial Officer, Cognito Therapeutics
02:10 PM
- 02:20 PM
EDT
Afternoon Innovation Showcase: Autonomize
02:20 PM
- 02:30 PM
EDT
Afternoon Innovation Showcase: Corticare
- Tim Innes, Executive Vice President, CortiCare
02:30 PM
- 02:40 PM
EDT
Afternoon Innovation Showcase: Archemedx
- Joel Selzer, CEO, ArcheMedX, Inc.
03:30 PM
- 05:00 PM
EDT
One to One Networking
05:00 PM
- 07:00 PM
EDT
Special Evening Event & Exhibits & Posters
View the ICNS abstract supplement here.
View the ICNS abstract supplement here.
View the ICNS abstract supplement here.
10:00 PM
- 11:55 PM
EDT
CNS Summit Masquerade Party
All are welcome!
All are welcome!
All are welcome!
Sunday, November 20
07:00 AM
- 07:45 AM
EDT
Breakfast
08:00 AM
- 12:00 PM
EDT
Keynote Sessions
- Carol Ferguson, VP, Women's Health Business Development, Organon
- Sharon Mates, Chairman and CEO, Intra-Cellular Therapies
- Tony Clapsis, SVP, Clinical Trial Services, CVS Health
- Jean Drouin, CEO, Clarify Health
- Isaac Galatzer-Levy, Senior Staff Research Scientist, Google
- Kushal Gohil, Chief Strategy Officer, Parexel
- Walter Greenleaf, Medical VR Expert, Stanford University, Virtual Human Interaction Lab
- Sabrina Johnson, President & CEO, Dare Bioscience
- John Mattison, CMIO, Operating Partner, KP ACP
- Alex Morgan, Partner, Khosla Ventures
- Irman Nasrullah, VP and Head, Collaborate to Cure Hub US, BD&L/OI, Bayer Pharmaceuticals
- Mike Rea, CEO, IDEA Pharma
- MaryAnne Rizk, Chief Strategy Officer, Medable
- Steve Rosenberg, CEO, uMotif
- Jordan Saxe, Head Of Healthcare Listings & Capital Markets, Nasdaq
08:05 AM
- 08:20 AM
EDT
Innovation Index Award
08:25 AM
- 08:35 AM
EDT
Innovation Showcase Award